The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...

This expansion positions Dupixent as the first targeted therapy for COPD ... Further boosting the pipeline, mid-stage drugs ...

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...

The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...

This expansion positions Dupixent as the first targeted therapy ... Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc ...

A major news story from Sanofi this month is that "The European Medicines Agency has approved Dupixent (dupilumab) to treat ...

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.